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Home » IVC Filter » Cook Celect IVC Filter
Cook Celect IVC Filter
The Celect IVC Filter may be associated with high rates of inferior vena cava perforation and other life-threatening complications. A growing number of IVC filter lawsuits filed against Cook Medical, Inc. claim that the anchor hooks on the Celect can become embedded in the vena cava, making removal of the device difficult.
Celect IVC Filter Investigation
The nationwide law firm of Bernstein Liebhard LLP is now investigating product liability claims against Cook Medical for injuries allegedly related to the Celect IVC filter. To learn more about the legal options available to those who may have been harmed by this device, please call (888) 994-5118 to discuss your case with one of our attorneys.
What is the Celect IVC Filter?
The Celect IVC filter is a small, wire, cage-like device that is inserted into the inferior vena cava in order to catch blood clots before they can travel to the lungs and become a pulmonary embolism. This and other IVC filters are indicated for patients at risk of blood clots, but for whom anticoagulant medications are inappropriate. A retrievable device, the Cook Celect is supposed to be removed after the patient is no longer at risk of a pulmonary embolism.
The Cook Celect IVC filter was approved in 2008, under the U.S. Food & Drug Administration’s 510(k) clearance program. This so-called “fast track” process allows a medical device to come to market without the benefit of human testing, just as long as its manufacturer can show that it is substantially equivalent in design to a product that was previously approved by the FDA.
Studies Question IVC Filter Safety
In recent years, a number of studies have raised questions about the safety of retrievable IVC filter, including the Cook Celect.
- February 2009: A study of 115 Celect patients reported good IVC filter retrieval rates. But some doctors had difficulty removing the device because it had become embedded in the vena caval wall
- April 2012: A study published in Cardiovascular and Interventional Radiology suggested the Cook Günther Tulip and Celect IVC filters were associated with a high risk of vena caval perforation with longer indwelling times. After 71 days, all 27 Celect patients showed some degree of vena caval perforation. Overall, fracture tilting was seen in 40% patients, while perforation occurred in 86% of the patients.
- June 2015: A study published in the Journal of Vascular and Interventional Radiology found a significant difference in the rate of vena cava perforation by filter struts between the Celect IVC filter and a competing device. Of the patients receiving the Celect, 43% experienced vena cava perforation. No such perforations were observed in those who received the competing filter.
FDA IVC Filter Warnings
In 2010, the U.S. Food & Drug Administration (FDA) issued the first of two warnings regarding retrievable IVC filters. The alert revealed that the FDA had received 921 reports of filter fracture, embolization, vena cava perforation, and migration since 2005, many of which resulted in adverse outcomes for patients. In an updated communication issued in May 2014, the FDA reminded doctors about the importance of retrieving IVC filters once the threat of pulmonary embolism has passed.
Cook IVC Filter Litigation
- October 2014: More than 2 dozen IVC filter lawsuits involving the Celect and other Cook IVC filters have been consolidated in a federal multidistrict litigation now underway in the U.S. District Court, Southern District of Indiana.
- December 2015: At least 156 cases were pending in the federal litigation involving Cook IVC filters.
- January 2016: A bellwether trial plan for the Cook IVC filter litigation calls for four cases to be prepared for trials that would get underway after September 15, 2016. Read More
- February 2016: Cook Medical is seeking a 60-day continuance of a settlement conference scheduled for next month in the federal litigation involving its Celect and Gunther Tulip IVC filters. The company asked for the delay to give its recently retained counsel additional time to review information surrounding the claims and to confer with the company. Read More
- July 2016: The federal court overseeing hundreds of Cook IVC filter lawsuits has chosen three cases for the litigation’s first bellwether trials, which are to be convened in 2017. According to an Order issued in the U.S. District Court, Southern District of Indiana, two of the bellwether cases were filed on behalf of Celect filter recipients, including the lawsuit designated for the proceeding’s first trial. Its outcome could provide valuable insight into how juries might decide similar claims. Read More
Do I Qualify to File a Cook Celect IVC Filter Lawsuit?
Individuals who allegedly suffered serious complications due to a Cook Celect IVC filter or similar device may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages. To learn more about filing a claim in this litigation, please contact Bernstein Liebhard LLP today at (888) 994-5118.
Last Modified: August 16, 2016